MAUDE Adverse Event Report: SHOCKWAVE MEDICAL, INC. SHOCKWAVE C2 CORONARY INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER

Model Number	C2IVL3012
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Perforation of Vessels (2135); Cardiac Tamponade (2226); Hemodynamic instability (4868)
Date of Event	02/01/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
An imaging case report was published on j-stage by the japanese coronary association (doi: 10.7793/jcad.30.24-00011).Catastrophic ellis type iii coronary perforation from a high-pressure scoring balloon post intravascular lithotripsy (ivl) therapy was reported in a case that occurred in japan.Following the use of a 3.0mm ivl, the patient underwent dilation with a 3.0mm scoring balloon catheter at 20 atm without prior imaging, resulting in vascular perforation.The patient also experienced hemodynamic collapse in which the physician promptly established venoarterial extracorporeal membrane oxygenation.A covered stent was successfully deployed.Approximately 400 ml of bloody pericardial fluid was drained by pericardiocentesis, and the cardiac tamponade was resolved.Final angiography demonstrated complete hemostasis of the ruptured vessel, and the patient was discharged after cardiac rehabilitation without any sequelae.The physician does not believe the c2 catheter caused the vascular perforation.There was no ivl device malfunction reported.
Additional Manufacturer Narrative
The device referenced in this report was not returned to shockwave medical, inc.Therefore, a physical examination cannot be performed.The cause of the perforation, hemodynamic instability, and cardiac tamponade could not be definitively determined based on the information available.The physician does not believe the c2 catheter caused the vascular perforation.There was no ivl device malfunction reported.Shockwave medical has controls in place to ensure devices are built to approved procedures and meet lot release acceptance criteria prior to being distributed.A review of the manufacturing and test documentation for subject lot does not reveal any issues with the manufacturing of the device.The device passed all of shockwave medical, inc.Acceptance criteria prior to shipping.

• Brand Name: SHOCKWAVE C2 CORONARY INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER
• Common Device Name: SHOCKWAVE C2 CORONARY INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER
• Manufacturer (Section D): SHOCKWAVE MEDICAL, INC.; 5403 betsy ross drive; santa clara CA 95054
• Manufacturer (Section G): SHOCKWAVE MEDICAL, INC.; 5403 betsy ross drive; santa clara CA 95054
• Manufacturer Contact: alexis weil ; 5403 betsy ross drive; santa clara, CA 95054
• MDR Report Key: 20153120
• Report Number: 3015053858-2024-00101
• Device Sequence Number: 14518821
• Product Code: QMG
• UDI-Device Identifier: 00195451000096
• UDI-Public: (01)00195451000096(17)250831(10)04A230802A
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P200039
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Literature,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2025
• Device Model Number: C2IVL3012
• Device Catalogue Number: C2IVL3012
• Device Lot Number: 04A230802A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/13/2024
• Initial Report FDA Received Date: 09/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/02/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SCORING BALLOON CATHETER - UNKNOWN MANUFACTURER
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female